College of Chiropodists of Ontario

College of Chiropodists of Ontario Standard of Practice for the Administration of Inhaled Substances and the Use of Sedation in a Member s Practice* INTRODUCTION This document represents the minimum standards of practice for the administration of inhaled substances and the use of sedation in a member s practice. 1 Since contravention of this standard may be considered professional misconduct, a member utilizing any type of sedative agent(s) and/or sedation modality(ies) must adhere to this standard, be appropriately trained, and regulate his or her practice accordingly, to comply with this standard of practice, the Chiropody Act, 1991, its regulations, and the by-laws of the College of Chiropodists of Ontario ( College ). CONTENTS Definitions of Sedation Levels Minimal Sedation, Conscious Sedation, Moderate Sedation, Deep Sedation, General Anaesthesia... 2 PART 1 Administration of Oxygen... 4 PART 2 General Standards for All Modalities of Sedation... 5 PART 3 Specific Standards for Particular Modalities... 9 A. Administration of Nitrous Oxide and Oxygen... 10 B. Administration of Nitrous Oxide and Oxygen with a Single Sedative Drug... 15 C. Oral Administration of a Single Sedative Drug... 21 Appendices... 24 * This standard must be read in conjunction with Ontario Regulation 203/94, made under the Chiropody Act, 1991, the College s by-laws in relation to the administration of inhaled substances in a member s practice, and the College s Guideline for Dealing with Office Medical Emergencies in the Podiatry and Chiropody Office Setting. 1 Where the term member is used in this standard, it means a member of the College of Chiropodists of Ontario, unless another meaning is clearly intended. 1

DEFINITIONS OF SEDATION LEVELS ***REGARDLESS OF WHICH SEDATION MODALITY OR COMBINATION OF SEDATION MODALITIES IS EMPLOYED, A MEMBER MUST LIMIT THE DEPTH OF SEDATION TO MINIMAL SEDATION, AS DEFINED BELOW.*** MINIMAL SEDATION Minimally depressed level of consciousness. With modalities aimed at producing minimal sedation, the patient responds normally to tactile stimulation and verbal commands. Although cognitive function and coordination may be modestly impaired, ventilator and cardiovascular functions are unaffected. Minimal sedation is usually accomplished by the use of one of the following modalities: 1. Administration of nitrous oxide and oxygen. 2. Administration of nitrous oxide and oxygen with a [single] 2 sedative drug. 3. Oral administration of a [single] 3 sedative drug. CONSCIOUS SEDATION Conscious sedation is a minimally to moderately depressed level of consciousness that retains the patient s ability to independently and continuously maintain an airway and respond appropriately to physical stimulation and verbal commands. It is produced by a pharmacological or non-pharmacological method or a combination thereof. Conscious sedation may be further divided into minimal sedation and moderate sedation as defined by the Characteristics of the Levels of Sedation and General Anesthesia (see Appendix I). MODERATE SEDATION Moderately depressed level of consciousness. With modalities aimed at producing moderate sedation, the patient responds purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained. Moderate sedation is usually accomplished by the use of one of the following modalities: 1. Oral administration of multiple sedative drugs, with or without nitrous oxide and oxygen. 2. Parenteral administration of a sedative drug(s) (intravenous, intramuscular, subcutaneous, sub-mucosal, or intranasal). 2 This standard does not anticipate any circumstance where a member would use more than one sedative drug in combination with nitrous oxide and oxygen. 3 This standard does not anticipate any circumstance where a member would use more than one sedative drug. 2

DEEP SEDATION A controlled state of depressed consciousness, accompanied by partial loss of protective reflexes, including inability to respond purposefully to verbal command. GENERAL ANAESTHESIA A controlled state of unconsciousness accompanied by partial or complete loss of protective reflexes including inability to maintain an airway independently and respond purposefully to physical stimulation or verbal command. It must be emphasized that the various levels of sedation and general anaesthesia are produced along a continuum, ranging from the relief of anxiety with little or no associated drowsiness (i.e. low level minimal sedation), up to and including a state of unconsciousness (i.e. general anaesthesia). It is not always possible to predict how an individual patient will respond and, at times, it can be difficult to precisely define the end-points of the various levels of conscious sedation (i.e. minimal sedation versus moderate sedation) and the starting points of deep sedation and general anaesthesia. Therefore, the agents and modalities used for conscious sedation must be used judiciously and carry a margin of safety wide enough to render unwanted loss of consciousness highly unlikely. In a member s practice, sedation modalities targeting various levels of minimal sedation may be used to reinforce positive suggestion and reassurance in a way which allows treatment to be performed with minimal physiological and psychological stress, and enhanced physical comfort. However, members inducing sedation must be able to diagnose and manage the physiological consequences of sedation as well as be able to rescue patients whose level of sedation becomes deeper than initially intended. Members must have the training, skills, drugs, and equipment to identify and manage such an occurrence until either the patient returns to the intended level of sedation without airway or cardiovascular complications or assistance arrives (e.g. emergency medical service). 3

PART 1 ADMINISTRATION OF OXYGEN When used alone oxygen is not considered a sedative agent. While the administration of oxygen is most commonly associated with the management of emergency situations (resuscitation, anaphylaxis, syncope, shock, convulsions, etc.), the decision to administer oxygen may also be made in non-emergent situations and is highly dependent on the varied and specific needs of each patient. Therefore, the decision to administer oxygen to a patient in a practice setting is dictated by the specific circumstances surrounding that patient and is at the discretion of the member. So too, are the specific levels of oxygen concentration and flow deemed appropriate in each specific case with the goal of maintaining or re-establishing a patient s normal physiologic oxygen saturation levels (94 98% in most patients, or 88 92% in chronic obstructive pulmonary disease patients). 4

PART 2 GENERAL STANDARDS FOR ALL MODALITIES OF SEDATION In addition to meeting the general requirements for sedation below, a member must meet the requirements for the specific modality being utilized, as set out in Part 3 of this standard. Sedation may be indicated to: Treat patient anxiety and pain associated with treatment. Enable treatment for patients who have cognitive impairment or motor dysfunction which prevents adequate treatment. Treat patients below the age of reason. Treat traumatic conditions. Treat patient anxiety and pain during invasive and/or prolonged treatment or procedures. Sedation is to be used only when indicated, as an adjunct to appropriate non-pharmacological means of patient management. It is the responsibility of the member to determine which patients are suitable candidates for the various sedative modalities and agents. A member wishing to administer sedation must, of course, have informed consent to do so and ensure the requirements below are met, namely those requirements in relation to office protocol and facilities and sedation protocol (as applicable to all modalities). OFFICE PROTOCOL AND FACILITIES 1. Before a member treats a patient who is to be sedated, the member must ensure that the member s office has present all of the sedation equipment and emergency drugs and equipment needed to meet the requirements of this standard of practice. 2. The following table outlines the basic drugs that must be included in the emergency kit immediately available, where a member is treating a patient who is to be sedated. 4 Generic Agent Mandatory Emergency Agents for Facilities in Which a Member Administers One or More Sedation Modalities Proprietary Agent Indications Oxygen Oxygen Most medical emergencies Epinephrine 1:1000 Solution Initial Adult Dose Adrenalin Anaphylaxis 0.1 mg IV or 0.3-0.5 mg IM Pediatric Dose 100% inhalation 100% inhalation 0.01 mg/kg (total pediatric dose not to exceed adult dose of 0.3 mg/kg) 4 Note that all members are required to maintain a medical emergency kit with basic drugs, as per the College s Guideline for Dealing with Office Medical Emergencies in the Podiatry and Chiropody Office Setting. 5

Asthmatic bronchospasm unresponsive to salbutamol/ albuterol 0.1 mg IV or 0.3-0.5 mg IM 0.01 mg/kg (total pediatric dose not to exceed adult dose of 0.3 mg/kg) Cardiac arrest 1 mg IV 0.01 mg/kg (total pediatric dose not to exceed adult dose of 0.3 mg/kg) Diphenhydramine Benadryl Allergic reactions 50 mg IV or IM 1 mg/kg (total pediatric dose not to exceed adult dose of 50 mg) Nitroglycerin Salbutamol (Int) Albuterol (US) Acetylsalicylic acid (Aspirin) Nitrostat Nitromist Ventolin Proventil Many Angina pectoris Asthmatic bronchospasm Acute myocardial infarction Hydrocortisone Many Allergic reactions and/or adrenal insufficiency crisis Glucose Tablets Aromatic ammonia or other respiratory stimulant Dex4 Glucose Tablets Aromatic ammonia or other respiratory stimulant Hypoglycemic event (conscious patient) Midazolam Versed Seizures/ convulsions Naloxone Narcan Opioid antagonism for opioid overdose Flumazenil Romazicon Benzodiazepine antagonism for benzodiazepine overdose 0.3 or 0.4 mg sublingual tablet or metered spray 2 puffs (100 micrograms per puff) 325 mg non-enteric coated tablet to be chewed Hydrocortisone 100 mg or equivalent dose IM or IV 1-2 tablets chewed prn in conscious patient No pediatric dose 1 puff (100 micrograms per puff) Not indicated Hydrocortisone 1-5 mg/kg 1-2 tablets chewed prn in conscious patient Syncope episode Inhaled as needed Inhaled as needed 5 mg IM 0.1-0.25 mg/kg IM (not to exceed adult dose of 5 mg) 0.4-2 mg IV (may repeat every 2-3 minutes prn) 0.2 mg IV infused over 30 seconds; may repeat with additional doses of 0.5 mg over 30 seconds at 1 minute intervals; not to exceed a total cumulative dose of 3 mg 0.01-0.1 mg/kg IV or IM (may repeat every minute, not to exceed 2 mg/dose) 0.01 mg/kg IV infused over 15 seconds (not to exceed 0.2 mg/dose); may repeat every minute; not to exceed total cumulative dose of 0.05 mg/kg or 1 mg (whichever is lower) 3. A member utilizing sedative agents in his or her practice must take reasonable precautions to prevent the unauthorized use of these substances for recreational or other improper purposes, by office staff and other individuals with access to the office and equipment. To do this, preventative strategies must include the following: 6

Maintaining an inventory (written log) of all sedative agents including narcotics, other controlled drugs and substances, including benzodiazepines and targeted substances, and nitrous oxide acquired by the practice. This log must record the procurement of these substances, including specific substance acquired, supplier, date, and name of individual confirming receipt of substance, the total amount acquired, and expiry date (if applicable). The log must be reconciled regularly. This log must be kept on file and presented for review by the College when requested by the Registrar or the College s Sedation Committee. Keeping all sedative agents in a locked storage cupboard. Keeping a log that accurately accounts for the use in the practice of all narcotics, other controlled drugs and substances, and nitrous oxide. This log must record the specific utilization of these substances, including specific substance utilized, date and total amount of substance utilized with correlating patient identifier, and name of individual who administered the substance. This log must be kept on file and presented for review by the College when requested by the Registrar or the College s Sedation Committee. Keeping careful control of blank prescription pads and never pre-signing prescription blanks. Using staff training sessions and meetings to discuss the dangers of drug and substance abuse, to remind staff of the safeguards and protocols in the office to prevent misuse of supplies, and to provide information about resources that are available to office and clinical staff to assist with wellness issues. The dates and length of the training sessions should be recorded so that the member can establish that this training has been done, if requested by the College. 4. Before a member treats a patient who is to be sedated, the member must ensure that the facility in which these modalities are utilized comply with all applicable building codes, including fire safety, electrical, and access requirements. The size and layout of the facility must be adequate for all procedures to be performed safely as well as to provide for the safe evacuation of patients, in case of an emergency. 5. Before a member treats a patient who is to be sedated, the member must ensure that the office in which these modalities are utilized is suitably staffed and equipped for the specific modality or modalities being utilized, as required in this standard. SEDATION PROTOCOL (APPLICABLE TO ALL MODALITIES) 1. Informed consent must be obtained from a patient, or his or her legal guardian, and must be documented in the patient record, prior to the administration of any oral sedative drug and/or nitrous oxide and oxygen. 2. An adequate, clearly recorded, current medical history, including present and past illnesses, hospital admissions, current medications and/or non-prescription drugs and/or herbal supplements, as well as dose, allergies (in particular to drugs), and a functional inquiry, along with an appropriate physical examination must be completed for each 7

patient prior to the administration of any form of sedation. For medically compromised patients, consultation with their primary healthcare practitioner may be indicated. This must be documented in the patient record, consistent in content with Appendix II. Additionally, the medical history must be reviewed for any changes at each appointment at which sedation is to be utilized and it must be documented in the permanent record of the patient. This medical history will assist the member in determining whether the patient is a suitable candidate for in-office use of a particular sedation modality or agent. 3. A determination of the patient s American Society of Anesthesiologists (ASA) Physical Status Classification (see Appendix III) as well as careful evaluation of any other factors which may affect the patient s suitability for a sedation modality or agent must be made prior to administration of the modality or agent. This ASA status must be documented in the permanent record. This ASA status will assist the member in determining whether the patient is a suitable candidate for in-office use of a particular sedation modality or agent. 4. Patients who are determined to be ASA IV and higher (as per Appendix III) are not considered acceptable candidates for the administration of any sedation modality outside of a hospital facility. The administration of oxygen is permissible to these patients at the member s discretion. A member must consult the patient s primary healthcare practitioner prior to sedation if the patient is determined to be ASA III and higher. 5. A member must at all times be vigilant not to exceed minimal sedation levels (see Definitions of Sedation Levels). Single agent choice in a carefully considered dose is a prudent approach to achieving this level of sedation. 6. Should the administration of any modality produce depression beyond that of minimal sedation level, the treatment or procedure must be halted and appropriate support procedures administered until the level of depression is no longer beyond that of minimal sedation, or if necessary, until additional emergency assistance is available. 7. A member must take into account the maximum dose of local anaesthetic that may be safely administered, especially for children, the elderly, and the medically compromised. Whenever sedation is used, the calculated maximum dose of local anaesthetic may need to be further adjusted to provide a greater margin of safety. 8. In order to avoid allegations of sexual or other impropriety, another person must be present in the treatment room at all times whenever the patient is sedated. 9. Minimal sedation techniques require the patient to be discharged to the care of a responsible adult. The only situation in which a member may exercise discretion as to whether a patient may be discharged unaccompanied is that in which nitrous oxide and oxygen sedation alone is the modality used. Regardless of the modality used to induce sedation, all patients must be specifically assessed for fitness for discharge by the member responsible for the administration of the sedation. 8

PART 3 - SPECIFIC STANDARDS FOR PARTICULAR MODALITIES The member must adhere to the College s standard of practice where providing sedation to a patient using any modality, including: the administration of nitrous oxide and oxygen alone; the administration of nitrous oxide and oxygen with a [single] 5 sedative drug; and the oral administration of a [single] 6 sedative drug. ***REGARDLESS OF WHICH SEDATION MODALITY OR COMBINATION OF SEDATION MODALITIES IS EMPLOYED, A MEMBER MUST LIMIT THE DEPTH OF SEDATION TO MINIMAL SEDATION, AS DEFINED IN THIS STANDARD.*** The member must adhere to the professional responsibilities of initial and ongoing member authorization by the College in conjunction with the requirements specific to the modality the member wishes to administer. The requirements for each modality are set out below. 5 This standard does not anticipate any circumstance where a member would use more than one sedative drug in combination with nitrous oxide and oxygen. 6 This standard does not anticipate any circumstance where a member would use more than one sedative drug. 9

A. ADMINISTRATION OF NITROUS OXIDE AND OXYGEN In addition to the requirements listed in Part 2, the following standard of practice applies when nitrous oxide and oxygen sedation are being used to induce sedation. MEMBER S QUALIFICATIONS In order for a member to administer nitrous oxide and oxygen sedation, the member is required to meet the following requirements: 1. Obtain an Inhalation Certificate from the College (for details, see the College s by-laws in relation to the administration of inhaled substances in a member s practice). 2. Successful completion of a training program, approved by the College, designed to produce competency in the administration of nitrous oxide and oxygen, either with or without a [single] 7 sedative drug. 8 3. Successful completion of a comprehensive pharmacologic training program, approved by the College, designed to produce competency in general clinical pharmacological principles and overall systems pharmacology, and meet the requirements needed to prescribe the relevant sedative and emergency drugs as set forth in the current regulations or as may otherwise be required for appropriate patient care. 9 4. Maintain competence by including ongoing training, courses, and/or other educational programs related to these modalities in professional continuing education planning. 5. Ensure that a member s clinical staff (which includes Authorized Sedation Monitors, as defined below) are prepared to recognize and treat adverse responses using appropriate emergency equipment and appropriate drugs, when necessary. A member will be required to establish written protocols for emergency procedures and review them with staff regularly. A written record of this must be kept on file and presented for review by the College when requested by the Registrar or the College s Sedation Committee. 6. Ensure that a member s clinical staff (which includes Authorized Sedation Monitors, as defined below) have the training and ability to perform basic life support (BLS) techniques. A member providing sedation must maintain current BLS certification (CPR 7 This standard does not anticipate any circumstance where a member would use more than one sedative drug in combination with nitrous oxide and oxygen. 8 This program will include: indications, contraindications, patient evaluation, patient selection, pharmacology of relevant drugs, administration of sedation agents and modalities, and management of potential adverse reactions, as they relate to the relevant sedation agents and modalities. 9 The member must meet the standard of practice set out in Ontario Regulation 203/94, made under the Chiropody Act, 1991, for prescribing sedative drugs. 10

Level HCP CPR Level for Health Care Providers) as a minimum. 10 BLS certification must be renewed at least every three years. USE OF AN AUTHORIZED SEDATION MONITOR Due to the inherent difficulties in safely providing foot care while simultaneously administering nitrous oxide and oxygen sedation, there must be a minimum of two individuals present during the administration of nitrous oxide and oxygen, whether or not the modality being used involves the concurrent use of an oral sedative drug. 11 A member inducing sedation must recognize he or she cannot adequately and responsibly monitor the patient while treating the feet and therefore must have the assistance of another person. Individual One: The first individual focuses principally on the foot care needs of the patient and must be a member currently registered with the College who is authorized by the College to administer a substance to a patient by inhalation, namely nitrous oxide and oxygen. 12 Individual Two: The second individual administers the sedation on the order of the member and must be continually monitoring the patient with regard to the sedation. This individual is able to dedicate his or her full attention to the sedation needs of the patient and also immediately attend to any issues arising from the sedation. Only the following persons ( Authorized Sedation Monitors ) may assist a member where the member intends to administer a substance to a patient by inhalation 13 : Another member currently registered with the College and authorized by the College to administer a substance to a patient by inhalation; A nurse currently registered with the College of Nurses of Ontario in the general class in the RN category acting under the required order and the direct control and supervision of a member currently registered with the College and authorized by the College to administer a substance to a patient by inhalation; A nurse currently registered with the College of Nurses of Ontario in the general class in the RPN category, who has obtained a two-year diploma in Practical Nursing from a Community College of Applied Arts or completed an enhanced medication course in the administration and monitoring of minimal sedation, acting under the required order and 10 It is strongly recommended that all members, whether or not intending to induce sedation, maintain current BLS certification (CPR Level HCP CPR Level for Health Care Providers). 11 Please note that this standard of practice has not been designed for the circumstance where a member arranges for a physician to provide sedation as the member tends to the foot care needs of the patient. 12 Individual One would not be required to be authorized by the College to administer a substance by inhalation where Individual Two was a member currently registered with the College who is authorized by the College to do so. 13 Please note that this standard of practice has not been designed for the circumstance where a member arranges for a physician to provide sedation as the member tends to the foot care needs of the patient. 11

the direct control and supervision of a member currently registered with the College and authorized by the College to administer a substance to a patient by inhalation. The member must ensure the Authorized Sedation Monitor has maintained current BLS certification (CPR Level HCP CPR Level for Health Care Providers) as a minimum. It is, of course, also incumbent on the member to ensure the Authorized Sedation Monitor is competent to perform the tasks being assigned to him or her. In the case of a nurse, the member performing the treatment must be present at all times in the office suite and immediately available in the event of an emergency. GAS DELIVERY SYSTEM REQUIREMENTS 1. Must have a fail-safe mechanism such that it will not deliver an oxygen concentration of less than 30% in the delivered gas mixture. 2. Must have pipeline inlet fittings, or pin-indexing, that do not permit interchange of connections with oxygen and nitrous oxide. 3. Must be checked regularly for functional integrity by appropriately trained personnel, function reliably and accurately, and receive appropriate care and maintenance according to manufacturer s instructions or annually, whichever is more frequent. A written record of this annual maintenance/servicing must be kept on file and presented for review by the College when requested by the Registrar or the College s Sedation Committee. 4. Must be equipped with a common gas outlet compatible with 15mm male and 22mm female conical connectors. 5. Must have readily available a reserve supply of oxygen ready for immediate use. This must be a portable E size cylinder attached with an appropriate oxygen regulator and flowmeter, as well as connectors, tubing, and a reservoir bag which allows the use of a full face mask for positive pressure resuscitative ventilation with 100% oxygen. 6. Must be used with only single use disposable masks with scavenging capabilities to prevent nosocomial cross contamination between patients and allow for the evacuated gas being exhaled by the patient. 7. Must be equipped with a properly functioning scavenging system installed per manufacturer s specifications. Such a system must include an accurate flowmeter, scavenging masks, and a vacuum system able to eliminate gases at a rate of at least 45 L per minute. These gases must be vented to the outside. 12

8. Must allow for single patient use of all components which come into direct contact with the patient. Components that do not come into direct contact with the patient must be appropriately cleaned and disinfected in accordance with the manufacturer s instructions. EMERGENCY EQUIPMENT AND DRUG REQUIREMENTS 1. Emergency equipment and drugs must be available at all times. Drugs must be current (not expired) and stored in a readily identifiable and organized fashion (i.e. labelled trays or bags). It is the member s responsibility to ensure that the office in which sedation is being performed is equipped with the following: Pulse oximeter, which model is approved by Health Canada; Sphygmomanometers and stethoscopes of appropriate sizes; Full face masks of appropriate sizes and connectors; and Current (unexpired) drugs for management of emergencies as detailed in the table, Mandatory Emergency Agents for Facilities in Which a Member Administers One or More Sedation Modalities (see Part 2). A written record of the equipment s annual maintenance/servicing and emergency drugs must be kept on file and presented for review by the College when requested by the Registrar or the College s Sedation Committee. SEDATION PROTOCOL 1. Review of the patient's medical history (as described in Part 2 and Appendix II) must be performed prior to the decision to use any form of sedation. 2. Appropriate pre-operative and written post-operative instructions must be provided to or for the patient. 3. No fasting requirements are necessary prior to (minimal) sedation using nitrous oxide and oxygen. The member, however, may recommend that only a light meal be consumed by the patient within 2 hours of the administration of nitrous oxide. 4. A flow rate of 5 to 6 liters/minute generally is acceptable for most patients. The flow rate can be adjusted upon observation of the reservoir bag. 5. 100% oxygen for 1 to 2 minutes followed by titration of nitrous oxide in 10% intervals is recommended. 6. The administration of nitrous oxide and oxygen must be slowly titrated to achieve the signs and symptoms of minimal sedation, with continuous and vigilant assessment of the level of consciousness, except in justifiable circumstances. 14 14 In these cases, the patient record must reflect the reasons for these circumstances. 13

7. The concentration of nitrous oxide administered with the intent of achieving (minimal) sedation must not exceed 50%, except in justifiable circumstances. 15 8. Nitrous oxide concentration may be increased during periods of increased stimulation (e.g. injection of local anaesthetic) and/or decreased during periods of less stimulation (e.g. ongoing anxiolysis once local anaesthetic has had effect). Tailoring the administration of nitrous oxide to the patient s needs will assist in preventing overmedication of the patient, reduce adverse effects, and provide a more positive overall sedation experience. 9. Patients receiving nitrous oxide and oxygen sedation must never be left unattended during the administration of these inhaled substances and must be continuously monitored by an Authorized Sedation Monitor. 10. Monitoring must consist of direct and continuous clinical observation for level of consciousness and assessment of vital signs which may include heart rate, blood pressure, and respiration pre-operatively, intra-operatively, and post-operatively, as necessary. It must also include the use of pulse oximetry pre-operatively, intra-operatively, and postoperatively. 16 Monitoring details must be recorded, at a minimum, every 15 minutes. 11. Once the nitrous oxide flow is terminated, 100% oxygen must be delivered for 3 to 5 minutes. 12. The patient s recovery status post-operatively must be specifically assessed and recorded. The decision to discharge a patient following the administration of nitrous oxide and oxygen sedation must be made by a member currently registered with the College and authorized by the College to administer the specific sedation agent or modality, who must remain in the office until that patient is fit for discharge. 13. Only fully recovered patients can be considered for discharge unaccompanied. If the patient has residual symptoms, the patient must be accompanied by a responsible adult. 14. Specific to sedation, the patient record must include the indication(s) for use of sedation and the rationale for the choice of sedation administered. In situations where nitrous oxide and oxygen have been administered, the record must also include the following information: the name of the Authorized Sedation Monitor, the nitrous oxide dosage (i.e., percentage of nitrous oxide and oxygen and flow rate), the duration of administration of the nitrous oxide and oxygen, post-treatment oxygenation procedure(s), record of preoperative, intra-operative, and post-operative monitoring, discharge summary, and any adverse effects. 15 In these cases, the patient record must reflect the reasons for these circumstances. 16 Children, the elderly, and the medically compromised including patients who are taking prescribed medication with sedative properties require more vigilant monitoring to ensure that the intended level of sedation is not exceeded. 14

B. ADMINISTRATION OF NITROUS OXIDE AND OXYGEN WITH A SINGLE SEDATIVE DRUG In addition to the requirements listed in Part 2, the following standard of practice applies when an oral route of administration of a [single] 17 sedative drug is used in combination with nitrous oxide and oxygen to induce sedation. MEMBER S QUALIFICATIONS In order for a member to administer nitrous oxide and oxygen sedation with a [single] 18 sedative drug, the member is required to meet the following requirements: 1. Obtain an Inhalation Certificate from the College (for details, see the College s by-laws in relation to the administration of inhaled substances in a member s practice). 2. Successful completion of a training program, approved by the College, designed to produce competency in the administration of nitrous oxide and oxygen, either with or without a [single] 19 sedative drug. 20 3. Successful completion of a comprehensive pharmacologic training program, approved by the College, designed to produce competency in general clinical pharmacological principles and overall systems pharmacology, and meet the requirements needed to prescribe the relevant sedative and emergency drugs as set forth in the current regulations or as may otherwise be required for appropriate patient care. 21 4. Maintain competence by including ongoing training, courses, and/or other educational programs related to these modalities in professional continuing education planning. 5. Ensure that a member s clinical staff (which includes Authorized Sedation Monitors, as defined below) are prepared to recognize and treat adverse responses using appropriate emergency equipment and appropriate drugs, when necessary. A member will be required to establish written protocols for emergency procedures and review them with staff regularly. 17 This standard does not anticipate any circumstance where a member would use more than one sedative drug in combination with nitrous oxide and oxygen. 18 This standard does not anticipate any circumstance where a member would use more than one sedative drug in combination with nitrous oxide and oxygen. 19 This standard does not anticipate any circumstance where a member would use more than one sedative drug in combination with nitrous oxide and oxygen. 20 This program will include: indications, contraindications, patient evaluation, patient selection, pharmacology of relevant drugs, administration of sedation agents and modalities, and management of potential adverse reactions, as they relate to the relevant sedation agents and modalities. 21 The member must meet the standard of practice set out in Ontario Regulation 203/94, made under the Chiropody Act, 1991, for prescribing sedative drugs. 15

A written record of this must be kept on file and presented for review by the College when requested by the Registrar or the College s Sedation Committee. 6. Ensure that a member s clinical staff (which includes Authorized Sedation Monitors, as defined below) have the training and ability to perform basic life support (BLS) techniques. A member providing sedation must maintain current BLS certification (CPR Level HCP CPR Level for Health Care Providers) as a minimum. 22 BLS certification must be renewed at least every three years. USE OF AN AUTHORIZED SEDATION MONITOR Due to the inherent difficulties in safely providing foot care while simultaneously administering nitrous oxide and oxygen sedation, there must be a minimum of two individuals present during the administration of nitrous oxide and oxygen, whether or not the modality being used involves the concurrent use of an oral sedative drug. 23 A member inducing sedation must recognize he or she cannot adequately and responsibly monitor the patient while treating the feet and therefore must have the assistance of another person. Individual One: The first individual focuses principally on the foot care needs of the patient and must be a member currently registered with the College who is authorized by the College to administer a substance to a patient by inhalation, namely nitrous oxide and oxygen. 24 Individual Two: The second individual administers the sedation on the order of the member and must be continually monitoring the patient with regard to the sedation. This individual is able to dedicate his or her full attention to the sedation needs of the patient and also immediately attend to any issues arising from the sedation. Only the following persons ( Authorized Sedation Monitors ) may assist a member where the member intends to administer a substance to a patient by inhalation 25 : Another member currently registered with the College and authorized by the College to administer a substance to a patient by inhalation; A nurse currently registered with the College of Nurses of Ontario in the general class in the RN category acting under the required order and the direct control and supervision of 22 It is strongly recommended that all members, whether or not intending to induce sedation, maintain current BLS certification (CPR Level HCP CPR Level for Health Care Providers). 23 Please note that this standard of practice has not been designed for the circumstance where a member arranges for a physician to provide sedation as the member tends to the foot care needs of the patient. 24 Individual One would not be required to be authorized by the College to administer a substance by inhalation where Individual Two was a member currently registered with the College who is authorized by the College to do so. 25 Please note that this standard of practice has not been designed for the circumstance where a member arranges for a physician to provide sedation as the member tends to the foot care needs of the patient. 16

a member currently registered with the College and authorized by the College to administer a substance to a patient by inhalation; A nurse currently registered with the College of Nurses of Ontario in the general class in the RPN category, who has obtained a two-year diploma in Practical Nursing from a Community College of Applied Arts or completed an enhanced medication course in the administration and monitoring of minimal sedation, acting under the required order and the direct control and supervision of a member currently registered with the College and authorized by the College to administer a substance to a patient by inhalation. The member must ensure the Authorized Sedation Monitor has maintained current BLS certification (CPR Level HCP CPR Level for Health Care Providers) as a minimum. It is, of course, also incumbent on the member to ensure the Authorized Sedation Monitor is competent to perform the tasks being assigned to him or her. In the case of a nurse, the member performing the treatment must be present at all times in the office suite and immediately available in the event of an emergency. GAS DELIVERY SYSTEM REQUIREMENTS 1. Must have a fail-safe mechanism such that it will not deliver an oxygen concentration of less than 30% in the delivered gas mixture. 2. Must have pipeline inlet fittings, or pin-indexing, that do not permit interchange of connections with oxygen and nitrous oxide. 3. Must be checked regularly for functional integrity by appropriately trained personnel, function reliably and accurately, and receive appropriate care and maintenance according to manufacturer s instructions or annually, whichever is more frequent. A written record of this annual maintenance/servicing must be kept on file and presented for review by the College when requested by the Registrar or the College s Sedation Committee. 4. Must be equipped with a common gas outlet compatible with 15mm male and 22mm female conical connectors. 5. Must have readily available a reserve supply of oxygen ready for immediate use. This must be a portable E size cylinder attached with an appropriate oxygen regulator and flowmeter, as well as connectors, tubing, and a reservoir bag which allows the use of a full face mask for positive pressure resuscitative ventilation with 100% oxygen. 6. Must be used with only single use disposable masks with scavenging capabilities to prevent nosocomial cross contamination between patients and allow for the evacuated gas being exhaled by the patient. 17

7. Must be equipped with a properly functioning scavenging system installed per manufacturer s specifications. Such a system must include an accurate flowmeter, scavenging masks, and a vacuum system able to eliminate gases at a rate of at least 45 L per minute. These gases must be vented to the outside. 8. Must allow for single patient use of all components which come into direct contact with the patient. Components that do not come into direct contact with the patient must be appropriately cleaned and disinfected in accordance with the manufacturer s instructions. EMERGENCY EQUIPMENT AND DRUG REQUIREMENTS 1. Emergency equipment and drugs must be available at all times. Drugs must be current (unexpired) and stored in a readily identifiable and organized fashion (i.e. labelled trays or bags). It is the member s responsibility to ensure that the office in which sedation is being performed is equipped with the following: Pulse oximeter, which model is approved by Health Canada; Sphygmomanometers and stethoscopes of appropriate sizes; Full face masks of appropriate sizes and connectors; and Current (unexpired) drugs for management of emergencies as detailed in the table, Mandatory Emergency Agents for Facilities in Which a Member Administers One or More Sedation Modalities (see Part 2). A written record of the equipment s annual maintenance/servicing and emergency drugs must be kept on file and presented for review by the College when requested by the Registrar or the College s Sedation Committee. SEDATION PROTOCOL 1. Review of the patient's medical history (as described in Part 2 and Appendix II) must be performed prior to the decision to use any form of sedation. 2. No fasting requirements are necessary prior to (minimal) sedation using the oral administration of a [single] 26 sedative drug with or without nitrous oxide and oxygen. The member, however, may recommend that only a light meal be consumed by the patient within 2 hours of the administration of nitrous oxide. 3. For the purposes of this document, the administration of an oral sedative intended to induce sedation refers to a [single] 27 oral dose administered to the patient while in the 26 This standard does not anticipate any circumstance where a member would use more than one sedative drug in combination with nitrous oxide and oxygen.. 27 This standard does not anticipate any circumstance where a member would use more than one sedative drug in combination with nitrous oxide and oxygen. 18

member s office. The administration of this [single] 28 oral dose must take into account the time required for drug absorption as well as the concurrent use of other medications which may impact the clinical effects of the administered dose. It is recommended that the full effect of the administered oral sedative has occurred prior to initiating treatment or beginning a procedure. 4. There are two possible exceptions to the recommendation that the oral sedative be administered in the member s office. One indication is if the member has determined that the patient requires an oral sedative to facilitate sleep the night prior to the member s treatment or procedure. The second indication is when the patient s anxiety is such that sedation is required to permit arrival to the member s office. In these two situations, the following additional requirements apply: The circumstances leading to a member s instructions to a patient to take a sedative drug prior to arriving at a member s office must be documented in the patient record. Each patient must be screened by the member at a prior appointment, with an appropriate medical history (as described in Part 2 and Appendix II). Only one sedative drug should be prescribed at any one time, preferably a benzodiazepine or an antihistamine. Opioids must not be used as pre-operative or intra-operative sedative drugs. The patient must be instructed not to drive a vehicle and must be accompanied to and from the member s office. In each case, clear written instructions must be given to the patient, or his or her legal guardian, explaining how to take the medication, the need for accompaniment, and listing the expected effects from this drug. 5. Knowledge of the administered oral sedative s time of onset, peak response, and duration of action is essential to avoid over-sedation. 6. The maximum recommended dose of an oral sedative must not be exceeded at any one appointment, as set out in the College s Guideline for Dealing with Office Medical Emergencies in the Podiatry and Chiropody Office Setting. Because sedation is produced along a continuum, it is not always possible to predict how specific individual patients will respond to any dose of a sedative drug. Members are encouraged to use the lowest effective dose to achieve the desired sedative effect, as per Appendix IV. 7. If an oral sedative has been administered, the practitioner must ensure that the full effect of the oral sedative has occurred before administering nitrous oxide. 28 This standard does not anticipate any circumstance where a member would use more than one sedative drug in combination with nitrous oxide and oxygen. 19

8. If an oral sedative has been administered, nitrous oxide and oxygen must be slowly titrated to achieve the signs and symptoms of minimal sedation with continuous and vigilant assessment of the level of consciousness, except in justifiable circumstances. 29 9. A flow rate of 5 to 6 liters/minute generally is acceptable for most patients. The flow rate can be adjusted after observation of the reservoir bag. 10. 100% oxygen for 1 to 2 minutes followed by titration of nitrous oxide in 10% intervals is recommended. 11. The concentration of nitrous oxide administered with the intent of achieving (minimal) sedation must not exceed 50%, except in justifiable circumstances. 30 12. Nitrous oxide concentration may be increased during periods of increased stimulation (e.g. injection of local anaesthetic) and/or decreased during periods of less stimulation (e.g. ongoing anxiolysis once local anaesthetic has had effect). Tailoring the administration of nitrous oxide to the patient s needs will assist in preventing overmedication of the patient, reduce adverse effects, and provide a more positive overall sedation experience. 13. Patients receiving this combination of sedative agents and modalities must never be left unattended during the administration of these inhaled substances and must be continuously monitored by an Authorized Sedation Monitor. 14. Monitoring must consist of direct and continuous clinical observation for level of consciousness and assessment of vital signs which may include heart rate, blood pressure, and respiration pre-operatively, intra-operatively, and post-operatively, as necessary. It must also include the use of pulse oximetry pre-operatively, intra-operatively, and postoperatively. 31 Monitoring details must be recorded, at a minimum, every 15 minutes. 15. Once the nitrous oxide flow is terminated, 100% oxygen must be delivered for 3 to 5 minutes. 16. The patient s recovery status post-operatively must be specifically assessed and recorded. The decision to discharge a patient following the administration of nitrous oxide and oxygen sedation, with or without the administration of an oral sedative drug, must be made by a member currently registered with the College and authorized by the College to administer the specific sedation agent or modality, who must remain in the office until that patient is fit for discharge. 29 In these cases, the patient record must reflect the reasons for these circumstances. 30 In these cases, the patient record must reflect the reasons for these circumstances. 31 Children, the elderly, and the medically compromised including patients who are taking prescribed medication with sedative properties require more vigilant monitoring to ensure that the intended level of sedation is not exceeded. 20

17. The patient must be discharged to the care of a responsible adult. Before doing so, the patient must be oriented i.e. to time, place, and person relative to the pre-anaesthetic condition, ambulatory, with stable vital signs, and showing signs of increasing alertness. 18. Written post-sedation instructions must be given. The patient must be instructed to not drive a vehicle, operate hazardous machinery, or consume alcohol for a minimum of 18 hours or longer if drowsiness or dizziness persists. 19. Specific to sedation, the patient record must include the indication(s) for use of sedation, the rationale for the choice of sedation administered, doses of all oral sedative drugs, and time of administration of all oral sedative drugs. In situations where nitrous oxide and oxygen have been administered, the record must also include the following information: the name of the Authorized Sedation Monitor, the nitrous oxide dosage (i.e., percentage of nitrous oxide and oxygen and flow rate), the duration of administration of the nitrous oxide and oxygen, post-treatment oxygenation procedure(s), record of pre-operative, intra-operative, and post-operative monitoring, discharge summary, and any adverse effects. 21

C. ORAL ADMINISTRATION OF A SINGLE SEDATIVE DRUG (NO NITROUS OXIDE IS USED) In addition to the requirements listed in Part 2, the following standard of practice applies when the oral route of administration of a [single] 32 sedative drug is used. This also applies to the sublingual route of administration. MEMBER S QUALIFICATIONS In order for a member to administer a [single] 33 sedative drug, the member is required to meet the following requirements: 1. Successful completion of a comprehensive pharmacologic training program, approved by the College, designed to produce competency in general clinical pharmacological principles and overall systems pharmacology, and meet the requirements needed to prescribe the relevant sedative and emergency drugs as set forth in the current regulations or as may otherwise be required for appropriate patient care. 34 2. Maintain competence by including ongoing training, courses, and/or other educational programs related to these modalities in professional continuing education planning. 3. Ensure that a member s clinical staff are prepared to recognize and treat adverse responses using appropriate emergency equipment and appropriate drugs, when necessary. A member will be required to establish written protocols for emergency procedures and review them with staff regularly. A written record of this must be kept on file and presented for review by the College when requested by the Registrar or the College s Sedation Committee. 4. Ensure that a member s clinical staff have the training and ability to perform basic life support (BLS) techniques. A member providing sedation must maintain current BLS certification (CPR Level HCP CPR Level for Health Care Providers) as a minimum. 35 BLS certification must be renewed at least every three years. EMERGENCY EQUIPMENT AND DRUG REQUIREMENTS 1. Emergency equipment and drugs must be available at all times. Drugs must be current (unexpired) and stored in a readily identifiable and organized fashion (i.e. labelled trays or 32 This standard does not anticipate any circumstance where a member would use more than one sedative drug. 33 This standard does not anticipate any circumstance where a member would use more than one sedative drug. 34 The member must meet the standard of practice set out in Ontario Regulation 203/94, made under the Chiropody Act, 1991, for prescribing sedative drugs. 35 It is strongly recommended that all members, whether or not intending to induce sedation, maintain current BLS certification (CPR Level HCP CPR Level for Health Care Providers). 22